A Review of Stability Indicating Methods and Forced Degradation Studies

Abstract

Stability testing of pharmaceutical products is a complex collection of processes requiring significant expense, time consumption, and scientific skill. In order to improve the quality, efficacy, and safety of a pharmaceutical product, stability testing of drug substances and products is an important step in determining the best storage options and recommending labeling guidelines. The forced degradation parameter performed under stability testing is Hydrolytic degradation, Oxidation degradation, Acidic degradation, Alkaline degradation, and Thermal degradation. In this paper, we present a comprehensive review of the current state of the art of Conventional Techniques and Hyphenated Techniques in the analysis of drug degradation products. We also provide an overview of recent advances in high-performance liquid chromatography (HPLC) and Method development of pharmaceutical drugs.

Drug-Modified Contact Lenses—Properties, Release Kinetics, and Stability of Active Substances with Particular Emphasis on Cyclosporine A: A Review

“…While other analytical methods are documented in the literature for assessing the stability of different active substances, HPLC stands out for its prevalent utilization. These include the following [ 141 ]: Nuclear magnetic resonance (NMR); Accelerated solvent extraction (ASE); Low-pressure liquid chromatography (LPLC); Thin-layer chromatography (TLC); Gas chromatography-mass spectrometry (GC-MS); Liquid chromatography–mass spectrometry (LC-MS); Capillary electrophoresis-mass spectrometry (CE-MS); Liquid chromatography–nuclear magnetic resonance (LC-NMR); Liquid chromatography Fourier-transform infrared (LC-FTIR). …”

“…While other analytical methods are documented in the literature for assessing the stability of different active substances, HPLC stands out for its prevalent utilization. These include the following [141]: • Liquid chromatography-nuclear magnetic resonance (LC-NMR); • Liquid chromatography Fourier-transform infrared (LC-FTIR).…”